Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy — A Multi-centric Study

Thomas, Niranjan; Abiramalatha, Thangaraj; Bhat, Vishnu; Varanattu, Manoj; Rao, Suman; Wazir, Sanjay; Lewis, Leslie Edward; Balakrishnan, Umamaheswari; Murki, Srinivas; Mittal, Jaikrishnan; Dongara, Ashish R.; Prashantha, Y N; Nimbalkar, Somashekhar

doi:10.1007/s13312-018-1317-1

Cited by 30 publications

(25 citation statements)

References 10 publications

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“…There were no significant differences in major adverse events or postnatal complications between the groups and no life-threatening adverse events in the TH group. In accordance with our results, the PCM-based cooling device has recently been shown feasible and safe when used in 11 tertiary NICUs in India 13. Our study confirms very stable temperatures in cooled infants with fluctuation of temperature (SD) of 0.27°C during intervention.…”

Section: Discussionsupporting

confidence: 90%

“…In accordance with our results, the PCM-based cooling device has recently been shown feasible and safe when used in 11 tertiary NICUs in India. 13 Our study confirms very stable temperatures in cooled infants with fluctuation of temperature (SD) of 0.27°C during intervention. The PCM mattress is produced locally and costs one-tenth of a servo-controlled, automated cooling device commonly used in HICs.…”

Section: Discussionsupporting

confidence: 82%

“…The PCM mattress is produced locally and costs one-tenth of a servo-controlled, automated cooling device commonly used in HICs. Compared with other low-cost, non-servo-controlled cooling devices PCM provides excellent temperature stability and requires less nursing input 13 14 33…”

Section: Discussionmentioning

confidence: 99%

“… 11 A survey from 2015 showed that many of the neonatal units in India which do not offer TH are unable to do so due to lack of cooling device and trained staff. 12 Phase changing material (PCM) has been shown to provide very stable temperatures, 13 14 but its efficacy in inducing a rapid fall in temperature or in maintaining stable temperatures during the cooling phase irrespective of the ambient temperature has been questioned. 15 PCMs consist of salt hydride, fatty acid and esters or paraffin, melting at a set point, and with the ability to store and release heat at a nearly constant temperature.…”

Section: Introductionmentioning

confidence: 99%

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Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial

Aker

Støen

Eikenes

et al. 2019

Arch Dis Child Fetal Neonatal Ed

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ObjectiveTo evaluate the neuroprotective effect of therapeutic hypothermia (TH) induced by phase changing material (PCM) on MRI biomarkers in infants with hypoxic-ischaemic encephalopathy (HIE) in a low-resource setting.DesignOpen-label randomised controlled trial.SettingOne neonatal intensive care unit in a tertiary care centre in India.Patients50 term/near-term infants admitted within 5 hours after birth with predefined physiological criteria and signs of moderate/severe HIE.InterventionsStandard care (n=25) or standard care plus 72 hours of hypothermia (33.5°C±0.5°C, n=25) induced by PCM.Main outcome measuresPrimary outcome was fractional anisotropy (FA) in the posterior limb of the internal capsule (PLIC) on neonatal diffusion tensor imaging analysed according to intention to treat.ResultsPrimary outcome was available for 22 infants (44%, 11 in each group). Diffusion tensor imaging showed significantly higher FA in the cooled than the non-cooled infants in left PLIC and several white matter tracts. After adjusting for sex, birth weight and gestational age, the mean difference in PLIC FA between groups was 0.026 (95% CI 0.004 to 0.048, p=0.023). Conventional MRI was available for 46 infants and demonstrated significantly less moderate/severe abnormalities in the cooled (n=2, 9%) than in the non-cooled (n=10, 43%) infants. There was no difference in adverse events between groups.ConclusionsThis study confirmed that TH induced by PCM reduced brain injury detected on MRI in infants with moderate HIE in a neonatal intensive care unit in India. Future research should focus on optimal supportive treatment during hypothermia rather than looking at efficacy of TH in low-resource settings.Trial registration numberCTRI/2013/05/003693.

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Section: Discussionsupporting

confidence: 90%

Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial

Aker

Støen

Eikenes

et al. 2019

Arch Dis Child Fetal Neonatal Ed

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“… 24 Nevertheless, cooling devices using phase change material is now commercially marketed in India, and several centres are using these devices. 25 …”

Section: Discussionmentioning

confidence: 99%

Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device

Oliveira

Kumutha

Eswar

et al. 2018

bmjpo

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Although therapeutic hypothermia (TH) is the standard of care for hypoxic ischaemic encephalopathy in high-income countries, the safety and efficacy of this therapy in low-income and middle-income countries (LMICs) is unknown. We aimed to describe the feasibility of TH using a low-cost servo-controlled cooling device and the short-term outcomes of the cooled babies in LMIC.DesignWe recruited babies with moderate or severe hypoxic ischaemic encephalopathy (aged <6 hours) admitted to public sector tertiary neonatal units in India over a 28-month period. We administered whole-body cooling (set core temperature 33.5°C) using a servo-controlled device for 72 hours, followed by passive rewarming. We collected the data on short-term neonatal outcomes prior to hospital discharge.ResultsEighty-two babies were included—61 (74%) had moderate and 21 (26%) had severe encephalopathy. Mean (SD) hypothermia cooling induction time was 1.7 hour (1.5) and the effective cooling time 95% (0.08). The mean (SD) hypothermia induction time was 1.7 hour (1.5 hour), core temperature during cooling was 33.4°C (0.2), rewarming rate was 0.34°C (0.16°C) per hour and the effective cooling time was 95% (8%). Twenty-five (51%) babies had gastric bleeds, 6 (12%) had pulmonary bleeds and 21 (27%) had meconium on delivery. Fifteen (18%) babies died before discharge from hospital. Heart rate more than 120 bpm during cooling (P=0.01) and gastric bleeds (P<0.001) were associated with neonatal mortality.ConclusionsThe low-cost servo-controlled cooling device maintained the core temperature well within the target range. Adequately powered clinical trials are required to establish the safety and efficacy of TH in LMICs.Clinical trial registration number NCT01760629.

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Neuronal Biomarkers in Predicting Neurodevelopmental Outcome in Term Babies with Perinatal Asphyxia

et al. 2020

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Phase Changing Material for Therapeutic Hypothermia in Neonates with Hypoxic Ischemic Encephalopathy — A Multi-centric Study

Abstract: Using phase changing material based cooling device and a standard protocol, it was feasible and safe to provide therapeutic hypothermia to asphyxiated neonates across different neonatal units in India. Maintenance of target temperature was comparable to standard servo-controlled equipment.

Cited by 30 publications

References 10 publications

Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial

Therapeutic hypothermia for neonatal hypoxic-ischaemic encephalopathy in India (THIN study): a randomised controlled trial

Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device

Neuronal Biomarkers in Predicting Neurodevelopmental Outcome in Term Babies with Perinatal Asphyxia

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